NCT07412613招募中3 期
A Randomized, Open-label, Controlled, Multicenter Phase 3 Clinical Trial of AK104 for Neoadjuvant/Adjuvant Treatment of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
Akeso1 个研究点 分布在 1 个国家目标入组 386 人开始时间: 2026年4月15日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 386
- 试验地点
- 1
- 主要终点
- Event Free Survival (EFS)
研究概览
简要总结
This is a randomized, open-label, controlled, multicenter phase 3 study. All patients are resectable microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer. The purpose of this study is to evaluate the efficacy and safety of neoadjuvant/adjuvant treatment of AK104 (Cadonilimab) versus adjuvant chemotherapy in patients with resectable MSI-H/dMMR colon cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign a written ICF.
- •≥ 18, ≤ 75 years old at the time of enrollment, regardless of sex.
- •Eastern Cooperative Oncology Organization (ECOG) performance status score of 0 or
- •Life expectancy greater than 2 years.
- •Histologically confirmed primary colon adenocarcinoma (without squamous carcinoma or sarcomatoid components); colon is defined as ≥ 12cm from the anal verge by colonscopy.
- •Participants with resectable stage IIB-III colon cancer according to the AJCC 8th staging, as assessed by imaging (enhanced CT or enhanced MRI) .
- •Microsatellite instability detection demostrates MSI-H (with 5 NCI-recommended microsatellite detection sites: BAT25, BAT26, D5S346, D2S123, D17S250, or combinations of other guidelines and clinically recognized site) , or mismatch repair detection demostrates dMMR (evaluating the expression of 4 MMR proteins: MLH1, MSH2, MSH6, PMS2 by immunohistochemistry, and positive expression is localized to the nucleus).
- •Before enrollment, the participant needs to be evaluated by the responsible surgeon to confirm whether he/she is eligible for radical R0 resection, and does not require combined organ resection based on medical history.
- •Female participants of childbearing potential must have a urine or serum pregnancy test within 3 days before the first dose (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test is required, and the serum pregnancy result shall prevail), and the result is negative. If a female participant of childbearing potential has sex with a male partner who is not sterilized, the participant must use an acceptable method of contraception from screening and must agree to use a contraceptive method continuously until 120 days after the last dose of study drug; Contraception should be discussed with the investigator as to whether to discontinue contraception after this time point.
- •If a non-sterilized male participant has sex with a female partner of childbearing potential, the participant must take an effective method of contraception from the beginning of screening until 120 days after the last dose; Contraception should be discussed with the investigator as to whether to discontinue contraception after this time point.
排除标准
- •Previously received any anti-tumor treatment for the study disease, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
- •Previously (within 3 years) or currently suffering from other malignant tumors, except for cured local tumors (such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, etc.).
- •Participated in treatment with investigation drugs or used investigation devices within 4 weeks prior to randomization.
- •History of immunodeficiency; tested positive for HIV antibodies; currently on long-term systemic corticosteroids or other immunosuppressive agents.
- •Known active tuberculosis (TB); subjects suspected of having active TB need clinical examination for exclusion; known active syphilis infection.
- •Known history of allograft organ transplantation or allograft hematopoietic stem cell transplantation.
- •Previous history of pneumonitis/interstitial lung disease requiring systemic corticosteroid treatment or currently having pneumonitis.
- •Experiencing severe infection within 4 weeks prior to randomization, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; having received systemic anti-infection treatment for active infection within 2 weeks prior to randomization (excluding antiviral therapy for hepatitis B or hepatitis C).
- •Subjects with active hepatitis B (HBsAg positive and HBV-DNA over 1000 copies/ml (200 IU/ml) or above the lower limit of detection, whichever is higher). Note: Subjects with hepatitis B are required to receive antiviral treatment throughout the study.
- •Pregnant or breastfeeding women.
- •Previously or currently having any disease, treatment, or abnormal laboratory test results that could confound study results, affect full participation in the study, or make participation not in the best interest of the participant.
研究组 & 干预措施
AK104
Experimental
Participants will receive AK104 before and after surgery
干预措施: Cadonilimab (AK104) (Drug)
Physician's choice of chemotherapy
Active Comparator
Participants will receive physician's choice of chemotherapy after surgery
干预措施: Capecitabine (Drug)
Physician's choice of chemotherapy
Active Comparator
Participants will receive physician's choice of chemotherapy after surgery
干预措施: 5- Fluorouracil (Drug)
Physician's choice of chemotherapy
Active Comparator
Participants will receive physician's choice of chemotherapy after surgery
干预措施: Calcium Folinate (Drug)
Physician's choice of chemotherapy
Active Comparator
Participants will receive physician's choice of chemotherapy after surgery
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Event Free Survival (EFS)
时间窗: Up to approximately 5 years
Time from randomization to disease progression, local or distant recurrence in post-surgery phase, or death due to any cause
Pathologic Complete Response (pCR) rate as assessed by investigator
时间窗: 1 month after surgery
Proportion of participants with post-surgery stage of ypT0N0 as assessed by investigator
次要结局
- Adverse event(Up to approximately 5 years)
- Overall Survival (OS)(Up to approximately 5 years)
- R0 resection rate(Up to approximately 2 years)
- Safety assessment(Up to approximately 5 years)
- Pharmacokinetics (PK)(Up to approximately 2 years)
- Anti-Drug Antibodies(ADAs)(Up to approximately 2 years)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma (ESCC)NCT07263919Akeso90
招募中
1 期
Phase I/II Clinical Study of JMT108 Injection for the Treatment of Advanced Malignant Melanoma and Urinary Tract TumorsUnresectable Locally Advanced or Metastatic Urinary Tract TumorsNCT07280832Shanghai JMT-Bio Inc.500
尚未招募
3 期
A Phase Ⅲ Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCLCNSCLCNCT07376382CSPC Megalith Biopharmaceutical Co.,Ltd.680
招募中
3 期
A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate CancerNCT07311694Jiangsu HengRui Medicine Co., Ltd.370
尚未招募
3 期
Famitinib Combined With SHR-A1811, Versus SHR-A1811 for CDK4/6 Inhibitors-resistent Advanced HR+/HER2- Breast Cancer With SNF4 SubtypeBreast CancerNCT07382687Fudan University248